PHASE II TRIAL OF PACLITAXEL, GEMCITABINE AND CISPLATIN IN PATIENTS WITH RELAPSING GERM CELL CANCER AFTER FIRST LINE CHEMOTHERAPY - relapse cis-tax-gem

Phase 1

• Conditions: The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.

• Registration Number: EUCTR2007-000618-35-SK
• Lead Sponsor: ATIONAL CANCER INSTITUTE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-14
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

- histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irrdiated) or elevatiom of AFP and/or elevatiom of beta-HCG
- patient previously treated with standard BEP (3 or 4 cycles)with relapse 1 month or more after favorable response on previous chemotherapy (CR or PR)
- male
- age greater than or equal to 18 years
- performance status 0,1,2 or 3
- adequate renal function
- signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Uncontrolled active severe clinical infection (CTC grade 3 or 4).
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow- up related to mental disorders.
* Grade 2 or greater peripheral neurophaty according to the CTC, version 3.0.
* Second malignancy other than basal or squamous cell skin cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.;Secondary Objective: * Overall survival<br>* Progression free survival<br>* Response rates (RECIST)<br>* Duration of response<br>* To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP;Primary end point(s): The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.